Dr. Nambiar said that combination studies with pirfenidone and nintedanib have shown that treatment with the antifibrotic agents combined is well tolerated. What were the most common adverse events, and is there any information yet on the efficacy of combination treatment?

Vancheri et al have recently published results from an open-label trial of nintedanib with add-on pirfenidone in patients with IPF (the INJOURNEY Trial). In this study, patients with IPF and FVC ≥50% predicted at screening who completed a 4–5 week run-in with nintedanib 150 mg bid without dose reduction or treatment interruption were randomized to nintedanib 150 mg bid with add-on pirfenidone (titrated to 801 mg tid) (n = 53), or nintedanib 150 mg bid alone (n = 52), open-label for 12 weeks. The primary endpoint was the percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12. Analyses were descriptive and exploratory. GI AEs were reported for 69.8% of patients treated with nintedanib with add-on pirfenidone and in 52.9% of patients treated with nintedanib alone. Diarrhea, nausea and vomiting were the most frequent AEs, occurring in 37.7%, 41.5% and 28.3% respectively, with combination treatment, compared with 31.4%, 11.8%, and 11.8% with nintedanib treatment alone. At 12 weeks, the mean absolute change from baseline in FVC was -13.3±17.4 mL in the nintedanib + pirfenidone group compared with -40.9 ± 31.4 mL for nintedanib treatment alone.

An open-label, single arm, 24 week safety and tolerability study of pirfenidone in combination with nintedanib has also been conducted in patients with IPF (NCT02598193), however the results of this study have not been published to date.

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